Unique Device Identification

Background

HIDA strongly supports the Unique Device Identification (UDI) system, signed into law in 2007, to reduce medical errors, facilitate device recalls, improve adverse event reporting, and ensure product integrity. HIDA Government Affairs staff has worked closely with Congress and the Food and Drug Administration (FDA) to identify and resolve challenges in UDI implementation.

What Members Need to Know

In response to feedback from HIDA and its members, the FDA announced on September 6, 2016, that it is extending the compliance deadline for certain Class II devices until September 24, 2018. The extension applies to a subset of medical devices and is not a blanket extension for all Class II devices. Devices covered in the extension include:

Collections of two or more different class II, or class II and class I devices (other than devices that are implantable, life-sustaining or life-supporting) packaged together, in which the devices in the package are not individually labeled with a UDI (medical convenience kits); and

Repackaged class II single-use devices (other than devices that are implantable, life-sustaining or life-supporting) that are not individually labeled with a UDI (single-use devices that are broken down to the “each” or unit of use).

OutlookIn addition to HIDA’s member-based UDI working group, HIDA is also engaged with the Association for Healthcare Resource and Materials Management (AHRMM) on a UDI LUM working group. With HIDA’s involvement as co-chair, the group has successfully developed a supply chain best practices for trading partners in regards to LUM and UDI implementation.

HIDA Government Affairs has also created a detailed UDI Class II compliance FAQ in follow-up to the Food and Drug Administration’s (FDA) earlier announcement.

The FAQ clarifies questions around how the compliance extension specifically impacts medical convenience kitting operations and the repackaging of single use devices for user in distributor low unit of measure (LUM) and/or just in time (JIT) programs. The document highlights additional key detail around UDI compliance impacting supply chain partners.

HIDA will continue to engage with Congress, industry partners and the FDA to further collaborate and help ensure a smooth transition to FDA compliance for our members.